OUR INVESTIGATION INTO THE REPORTED DISPLAY ISSUE HAS CONCLUDED THAT THE ROOT CAUSE WAS DUE TO UNIQUE IDENTIFIERS NOT BEING PROVIDED AS SPECIFICALLY REQUIRED IN THE PICIS STANDARD LABORATORY INTERFACE SPECIFICATIONS. PICIS CLIENT OPERATIONS WAS ABLE TO WORK WITH THE HOSPITAL TO CHANGE THE CONFIGURATION OF THE INTERFACE TO CONCATENATE THE TIME STAMP FIELD WITH THE LAB IDENTIFIER TO INCLUDE THE TIME STAMP AS PART OF THE UNIQUE IDENTIFIER. THIS INTERFACE CONFIGURATION RESULTS IN THE BLOOD GAS ANALYZER DATA FEED TO BE PROCESSED AS A NEW DATA FEED AND PREVENTS THE ABILITY TO UPDATE DATA, WHICH IS ACCEPTABLE FOR THIS BLOOD GAS ANALYZER INTERFACE PER THE HOSPITAL. PICIS CLINICAL SOLUTIONS HAS INITIATED A PREVENTIVE CAPA ON THIS MATTER. AS A PRECAUTIONARY MEASURE, PICIS CLINICAL SOLUTIONS, INC. INTENDS TO SEND A NOTICE TO POTENTIALLY AFFECTED CUSTOMERS WITH THE STANDARD LABORATORY INTERFACE. THIS COMMUNICATION IS INTENDED TO REMIND HOSPITALS OF THE IMPORTANCE OF PROVIDING UNIQUE IDENTIFIERS AS SPECIFIED IN THE INTERFACE SPECIFICATIONS DOCUMENTATION AND NOTIFY THEM OF THE POSSIBLE RISK OF A SOURCE MEDICAL DEVICE (IN THIS CASE THE BLOOD GAS ANALYZER) REBOOTING AND REUSING IDENTIFIERS AND THE RISK OF POTENTIAL DISPLAY ISSUES IF THE HOSPITAL'S SOURCE MEDICAL DEVICE DOES NOT PROVIDE UNIQUE IDENTIFIERS AS REQUIRED BY PICIS INTERFACE SPECIFICATIONS. ADDITIONALLY, PICIS CLINICAL SOLUTIONS PLANS TO ADD A STATEMENT TO THE STANDARD LABORATORY INTERFACE SPECIFICATIONS DOCUMENT STATING THAT 'IF UNIQUE IDENTIFIERS ARE NOT PROVIDED AS SPECIFIED, PICIS CLINICAL SOLUTIONS CANNOT GUARANTEE THAT DATA WILL BE DISPLAYED AS EXPECTED'. IN SUMMARY, THE PICIS SYSTEM DID NOT CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT NOR DID THE SYSTEM MALFUNCTION. THE PICIS APPLICATION OPERATED AS INTENDED AND ACCORDING TO THE INTERFACE SPECIFICATIONS DOCUMENT, HOWEVER IN AN ABUNDANCE OF CAUTION PICIS CLINICAL SOLUTIONS IS PROVIDING THIS MEDICAL DEVICE REPORT TO THE FDA.
D
Patient 1
THE PERIOPERATIVE AND CRITICAL CARE SOFTWARE (THE APPLICATION) OFFERED BY PICIS CLINICAL SOLUTIONS, INC. (PICIS) IS DESIGNED TO INTERFACE WITH CERTAIN MEDICAL DEVICES AND DISPLAY DATA ORIGINATED FROM THESE DEVICES. IN (B)(6) 2015, A BLOOD GAS ANALYZER USED IN THE NEONATAL UNIT OF THE HOSPITAL MALFUNCTIONED AND NEEDED TO BE REBOOTED SEVERAL TIMES IN A SHORT PERIOD OF TIME. AS A CONSEQUENCE DATA IDENTIFIERS WERE RE-USED BY THE BLOOD GAS ANALYZER. THE APPLICATION PROCESSED THE DATA GENERATED BY THE BLOOD GAS ANALYZER ON (B)(6) 2015 AS AN UPDATE OF DATA GENERATED ON (B)(6) 2015; THIS UPDATE RESULTED IN LABORATORY VALUES FROM (B)(6) 2015 VALUES. THE DOCTOR VIEWED THE APPLICATION DISPLAY AND NOTICED THE LABORATORY VALUES WERE NOT AS EXPECTED AND WENT TO THE SOURCE MEDICAL DEVICE (THE BLOOD GAS ANALYZER) TO VIEW A PRINT-OUT OF THE LABORATORY VALUES. NO INJURY TO THE PATIENT RESULTED FROM THIS INCIDENT. THE COMPLAINT SUBMITTED BY THE HOSPITAL AND RECEIVED ON JULY 14, 2015 BY PICIS INDICATED THE RISK THAT A DOCTOR COULD MAKE A WRONG DECISION BASED ON THE DATA DISPLAYED BY THE APPLICATION. HOSPITAL STATEMENT TRANSLATED FROM SPANISH TO ENGLISH: "FOR WHAT WE KNOW, THE DOCTRESS MIGHT HAVE TAKEN A WRONG DECISION BECAUSE PICIS WAS DISPLAYING WRONG INFORMATION"...HOWEVER IN THIS CASE THE DOCTOR VIEWED THE BLOOD GAS ANALYZER PRINT-OUT FOR THE LABORATORY VALUES. UPON INVESTIGATION BY PICIS, IT WAS DETERMINED THAT THE APPLICATION DID NOT MALFUNCTION, BUT RATHER OPERATED AS INTENDED AND AS OUTLINED IN THE INTERFACE SPECIFICATIONS DOCUMENT PROVIDED TO CLIENTS. THE ABILITY TO UPDATE DATA IS A FEATURE REQUIRED BY THE MAJORITY OF THE CLIENTS AND THE APPLICATION SPECIFICATIONS REQUIRE THAT UNIQUE IDENTIFIERS BE PROVIDED. ALTHOUGH NO INJURY TO THE PATIENT RESULTED FROM THIS INCIDENT NOR DID THIS COMPLAINT REPRESENT A PRODUCT MALFUNCTION, IN AN ABUNDANCE OF CAUTION PICIS CLINICAL SOLUTIONS IS PROVIDING THIS MEDICAL DEVICE REPORT.